Faculty of Dentistry, Universiti Malaya
Kuala Lumpur, 50603, Malaysia
Location status: Recruiting
NCT Number: NCT06759896
The goal of this clinical trial is to compare the effectiveness of a protraction facemask and upper partial fixed appliance in correcting anterior crossbite in growing children with class III malocclusion. It will also learn about the patients perceptions of these treatments. The main questions it aims to answer are:
i. What is the rate of success in achieving anterior crossbite correction with the protraction facemask and upper partial fixed appliance? ii. Are there any significant differences in the dental, skeletal and soft tissue outcomes between the two treatment groups? iii. What are the patient's perceptions associated with each treatment modality received.
iv. What is the incidence of adverse effects or complications and breakages associated with each treatment modality?
Participants will be randomly assigned to one of two groups: 1) protraction facemask; or 2) upper partial fixed appliance. After investigators decide which group participants will be in, investigators will take some standard records for the study before starting the treatment. These records include:
1. Making moulds of their teeth to create study models 2. Taking a side-view X-ray of their head (called a lateral cephalometric radiograph)
Additionally, the participant will need to fill out a quick 5-minute survey called the Child Perceptions Questionnaire 8-10 (CPQ8-10). It has 25 short questions. The participant will do this survey at four different times: 1) before starting the treatment; 2) 3 months into the treatment; 3) 6 months into the treatment; and 4) after the treatment is done.
Investigators will set up appointments for the treatment based on the type assigned. Once the treatment starts, investigators will see the participant every six weeks until it is finished.
If the participant gets a protraction facemask, investigators will put a fixed expander appliance in the mouth at the palate. Investigators will teach them how to activate the appliance once a day for seven days. Afterwards, the participant will use the protraction facemask with elastics connecting the appliance in the mouth and the protraction facemask. The participant must wear it for 14 hours a day, at night.
If the participants gets an upper fixed partial appliance, investigators will bond upper fixed appliances in the mouth.
Investigators will teach the child how to clean the appliance and their mouth to avoid any potential problems or side effects during the treatment.
Interested in participating?
Request Info7 year–10 year
All sexes
Interventional
Not applicable
Kuala Lumpur, 50603, Malaysia
Location status: Recruiting
Upper partial fixed appliance / 2 by 4 appliance (refer figure 3.7) will be used in this study by using bracket set (119-142 Unitek™ Gemini Bracket MBT™ U/L 5x5 0T-Cuspid 3Hk) with molar bands (3M™ Victory Series™ First Molar Bands) or buccal tubes (3M™ Victory Series™ Superior Fit Buccal Tubes) and upper nickel titanium archwires (3M™ Unitek™ Nitinol Heat-activated Archwire) and upper stainless steel archwires (3M™ Unitek™ Permachrome Standard Archwire) . The archwire sequence are listed below:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients assigned to intervention 1 will utilize the Petit protraction facemask, in conjunction with a rapid maxillary expansion (RME). This facemask consists of a forehead pad and chin pad linked by a sturdy steel support rod.
Upper partial fixed appliance / 2 by 4 appliance will be used in this study by using bracket set (119-142 Unitek™ Gemini Bracket MBT™ U/L 5x5 0T-Cuspid 3Hk) with molar bands (3M™ Victory Series™ First Molar Bands) or buccal tubes (3M™ Victory Series™ Superior Fit Buccal Tubes) and upper nickel titanium archwires (3M™ Unitek™ Nitinol Heat-activated Archwire) and upper stainless steel archwires (3M™ Unitek™ Permachrome Standard Archwire) .
Time frame: Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months
From Lateral cephalometric
Time frame: Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months
From lateral cephalometric
Time frame: Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months
Study model to measure dental changes
Time frame: Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months
Study model to measure canine and molar relationship changes based on British Standard Institution classification (Class I; Class II - 1/4 , 1/2, 3/4 , full ; Class III - 1/4 , 1/2, 3/4 , full)
Time frame: Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months
From lateral cephalometric
Time frame: Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months
From lateral cephalometric
Time frame: From issuance appliance date to the end of treatment at 3 months, 6 months and after appliance removal
Child Perception Questionnaire 8-10 will be used in this study to assess oral health-related quality of life scores for all participants at this time point:
Time frame: From issuance appliance date to the end of treatment at 3 months, 6 months and after appliance removal
The number of breakages, injuries or any other adverse effects that happened throughout the treatment time will be recorded
Interested in participating?
Request InfoUniversity of Malaya
Other
Comparison Between Protraction Facemask and Upper Partial Fixed Appliance for Early Class III Intervention: a Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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